BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
FDA device recall Z-0466-2007 · posted 2007-01-09 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
- Action taken
- An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- HTW
- Quantity affected
- 107 in US.
- Distribution
- Nationwide to distributors, hospitals and Integra Sales Reps.
- Date initiated
- 2006-11-10
- Date posted
- 2007-01-09
- Date terminated
- 2008-04-16
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BOLD SCREW (K990622) | New Deal, S.A. | 1999-04-29 |